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General Indications:

In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures. Specific indications:

1. Metacarpus, proximal and middle phalangeal bones

2. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

Deviet Desertifically cleared under K081588, consists of plates and fixation devices used:

General indications:

In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures. Specific indications:

1. Metacarpus, proximal and middle phalangeal bones

2. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

The purpose of this Special 510k is to expand the plate sizing and geometry options, and to add a marketing claim. The addition of the plate sizes and geometries are intended to give the user more options to better accommodate varying patient anatomy and varying surgical situations. There are 51 additional plates of varying lengths, widths, thicknesses and contours. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. The added marketing claim is designed to highlight the products use in reconstructive procedures of the thorax which is already covered by the specific indications for use of the predicate device.

The provided text describes a Special 510(k) submission for the BioBridge® Plating System, which is a metallic bone fixation device. The purpose of this submission is to expand the plate sizing and geometry options and add a marketing claim. The underlying technology and intended use remain unchanged from the predicate device (K081588).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes mechanical testing of the device modifications. It does not refer to clinical test sets involving patients or patient data. Therefore, questions regarding "sample size for the test set" and "data provenance" in a clinical context are not applicable to this submission. The "test set" in this context refers to the physical samples of the modified plates subjected to mechanical tests. The specific number of samples for each mechanical test (bending, 4-point bend, simulated use) is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as the submission focuses on mechanical performance testing of a physical device, not on the interpretation of medical data by experts. The "ground truth" here is the physical measurement of mechanical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as there is no human interpretation of data requiring adjudication. The assessment is based on objective mechanical test results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a metallic bone fixation system, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical testing conducted, the "ground truth" would be the physical measurements and engineering specifications for the bending strength, 4-point bend, and simulated use performance of the plates. These are objective, quantifiable metrics.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical testing of a physical medical device.

9. How the ground truth for the training set was established

This question is not applicable as there is no training set.

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The ACUTE Innovations® Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum.

The ACUTE Innovations® Modular RibLoc System consists of plates and screws for fractures, fusions, and osteotomies. The plates are pre-contoured to minimize bending which is done intraoperatively. Instrumentation is supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium or titanium alloy.

The provided text describes a 510(k) summary for the ACUTE Innovations Modular RibLoc Fixation System. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo performance characteristics through extensive clinical studies.

Therefore, much of the information requested, such as specific acceptance criteria and detailed study designs involving human subjects, AI assistance, or pathology-based ground truth, is not typically found in a 510(k) summary for a device like a bone fixation system. Instead, the evaluation relies heavily on preclinical testing and comparison to existing devices.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document states: "The non-clinical tests performed by the company include an analysis of strength of the ACUTE Innovations® Modular RibLoc plates. The results of the performed tests demonstrate that the ACUTE Innovations® Modular RibLoc System is substantially equivalent to legally marketed predicate devices."

This implies that the acceptance criteria are related to mechanical strength and performance and that the device's performance met those criteria by demonstrating substantial equivalence to predicate devices. However, specific numerical acceptance criteria (e.g., "withstanding X N of force for Y cycles") and corresponding reported performance values are not explicitly detailed in this summary.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for the preclinical testing.
• Data Provenance: The preclinical testing was performed by "the company" (ACUTE Innovations, LLC), suggesting it was internal testing. The origin country is likely the USA, where the company is located. It would be considered prospective for the purposes of these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable or not provided for this type of preclinical testing. Ground truth for mechanical strength tests typically comes from engineering measurements and relevant industry standards, not expert medical consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable for preclinical mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This device is a mechanical rib fixation system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the preclinical testing mentioned, the "ground truth" would be established by engineering standards and measurements of mechanical properties (e.g., strength, fatigue life) compared against established performance benchmarks for similar predicate devices.

8. The sample size for the training set:

This is not applicable, as there is no machine learning or AI component described that would require a "training set."

9. How the ground truth for the training set was established:

This is not applicable for the same reason as above. If there were a training set, the ground truth establishment method would depend on the specific task (e.g., expert annotation for image recognition, lab results for predictive models).

Summary of what is known based on the provided text:

• Acceptance Criteria (Implied): Substantial equivalence in mechanical strength and performance to predicate devices (MedXpert STRATOS, ACUTE Innovations® RibLoc System, ACUTE Innovations Sternal Fixation System).
• Study Proving Acceptance: "Preclinical Testing" which included "an analysis of strength of the ACUTE Innovations® Modular RibLoc plates."
• Device Performance: The tests "demonstrate that the ACUTE Innovations® Modular RibLoc System is substantially equivalent to legally marketed predicate devices."

The 510(k) pathway is designed to demonstrate that a new device is as safe and effective as (substantially equivalent to) a legally marketed predicate device, often relying on non-clinical data for devices like bone fixation systems. It does not typically require the extensive clinical trials or AI-specific validation metrics that would be associated with software as a medical device or novel therapeutic approaches.

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The ACUTE Innovations® Sternal Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

The ACUTE Innovations® Sternal Fixation System consists of plates and accessories as well as a cerclage-based device to provide fixation for sternotomies and sternal fractures. The plate designs for the Sternal Fixation System match the general anatomy of the sternum. The components of the ACUTE Innovations® Sternal Fixation System are made of commercially pure titanium, titanium alloy or stainless steel.

The provided text is a 510(k) summary for the ACUTE Innovations® Sternal Fixation System, a medical device for sternal fixation. It details the device's indications for use, description, and comparison to predicate devices to demonstrate substantial equivalence.

However, the document does not describe an acceptance criteria table, device performance report, or a study (e.g., clinical, standalone, or comparative effectiveness) that would typically involve statistical analysis of a test set, expert ground truth, or MRMC studies. The "study" mentioned consists of non-clinical mechanical tests.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is the information that can be extracted or deduced, along with explanations for what cannot be found:

1. A table of acceptance criteria and the reported device performance

Explanation: The document states that the device's performance was evaluated through non-clinical tests (bending strength and tensile testing) to demonstrate substantial equivalence to predicate devices. However, it does not explicitly list specific numerical acceptance criteria for these tests nor provide quantitative performance results. The acceptance criterion is generally framed as "substantially equivalent" to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable. The "tests" mentioned are non-clinical mechanical tests on the device components, not tests involving patient data or a "test set" in the context of AI/diagnostic device evaluation.
• Data provenance: Not applicable. These were laboratory mechanical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. As this was a non-clinical device for physical fixation, no human experts were used to establish ground truth in the context of interpretation of images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There was no clinical or interpretive test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, which is not the case for a sternal fixation system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical implant, not a standalone algorithm or a device requiring human-in-the-loop performance evaluation in the context of AI or diagnostic imaging. The "standalone" performance here refers to the device's physical and mechanical properties tested in a lab setting.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Ground Truth Type: For the non-clinical tests, the "ground truth" was established by engineering standards and direct measurement of physical properties (bending strength, tensile strength) to compare against the known properties or performance of predicate devices. The concept of "expert consensus," "pathology," or "outcomes data" for ground truth is not applicable here as it refers to a physical, non-diagnostic device.

8. The sample size for the training set

• Not applicable. The device is a physical implant, not an AI or machine learning model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for this type of device.

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In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and, maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft subsitives, or bone fragments from comminuted fractures), in trauma and reconstructive procedures.

Specific indications include: I. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible, 2. Metacarpus, proximal and middle phalangeal bones, 3. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax.

The Re-Zorb™ Plating System consists of plates, fixation devices, and associated instrumentation. The plates are offered in lengths of 60 and 110mm, and widths of 14 and 20mm. All plates are 1.6mm thick with uniformly distributed fixation holes and a polished finished. Fixation devices included in the system consist of screws and tacks. The screws and tacks are offered in 2.7mm diameters and lengths ranging from 8 to 40mm. The plates, screws, and tacks are injection molded from poly (1-lactide-co-D, L-lactide) 70:30, which gradually lose strength in vivo and are provided sterile. Suture can also be used in conjunction with the plates.

The provided text describes a 510(k) summary for the ACUTE Innovations® LLC Re-Zorb™ Plating System. This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and mechanical properties, rather than presenting a study involving AI or human reader performance. Therefore, many of the requested criteria related to AI device performance evaluation, human reader studies, and ground truth establishment are not applicable or detailed in this submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI device. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The submission describes a medical device (plating system) cleared through the 510(k) pathway, which primarily relies on technological comparison and non-clinical testing rather than clinical study data from a test set of patient cases. No test set in the context of diagnostic performance or AI evaluation is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There is no mention of a test set requiring expert ground truth establishment for a diagnostic or AI performance evaluation. The safety and effectiveness are established through comparison to a predicate and performance data on the device's material and mechanical properties.

4. Adjudication Method for the Test Set

Not applicable. No test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance

No, an MRMC comparative effectiveness study was not done. The device is a bone plating system, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. The device is a physical medical implant.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic or AI performance. The "ground truth" for the device's safety and effectiveness relies on established material science, mechanical testing standards, and a comparison to a legally marketed predicate device (Inion FreedomPlate™).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is involved.

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The Acute Bone Screw is a general purpose screw intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the thorax (ribs, sternum, clavicle, scapula).

The Acute Bone Screws consists of bone screws of varying lengths. The screws are partially and fully threaded, have a head with a hex drive, are cannulated or solid, and can be used with or without a plate or washer. The screws are manufactured out of titanium per ASTM F-136 and are provided non-sterile.

The provided text does not describe acceptance criteria, device performance metrics, or a study to prove the device meets acceptance criteria.

Instead, the document is a 510(k) summary for a medical device called "Acute Bone Screw." This type of submission to the FDA focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than reporting on specific performance studies or acceptance criteria for the new device.

Here's why the requested information cannot be extracted from this document:

• No acceptance criteria or device performance reported: The document explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This means the submission did not include performance metrics or acceptance criteria as it was deemed unnecessary for demonstrating substantial equivalence for this type of device.
• Focus on substantial equivalence: The core argument of the 510(k) is that the "Acute Bone Screw" is "substantially equivalent" to predicate devices (Macropore OS Reconstruction System K024169 and Acumed Cortical Bone Screw K942340) based on shared technological characteristics (Titanium per ASTM F-136) and similar intended use.
• No studies described: Since performance data and tests were deemed "not applicable," there is no mention of a study, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, it is not possible to fill out the requested table or answer the questions based on the provided text.

The document concludes that "Based upon the similarities of the Acute Bone Screw and the predicate devices studied, the safety and effectiveness of the Acute Bone Screw is substantially equivalent to the predicate devices referenced." This implies that the 'acceptance criteria' were met by demonstrating sufficient similarity to already approved devices, rather than through novel performance testing.

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